This invention relates to a device used to assist a medical professional in the care of patients, and more particularly to protect the professional during the transfer of body fluids collected from the patient. The invention has general application and is especially suited for the transfer of blood from a syringe to test tubes as required during the tasks associated with the general area of phlebotomy.
Exposure of the health care professional or assistant to inadvertent sticking by a syringe needle in the process of transferring body fluids from the patient to other containers for laboratory evaluation is a real and constant safety problem. This is a critical problem when the transfer must occur outside the controlled conditions of the laboratory. For example, transfer of a body fluid frequently occurs in the patients room, at night, without the patient's cooperation and at the same time other tasks are being performed. Such is the case with phlebotomy and the tasks associated with transferring blood to test tubes by a phlebotomist. An accidental needlestick of the health care provider by the syringe needle provides a direct contact with the body fluids, including blood, of the patient. Such contact exposes the provider to the same infection as that of the patient and appropriate testing and treatment must be done.
A 1992 "Q-Probes" study by The College of American Pathologists showed a summary of the frequency and types of accidents and occupational injuries occurring within clinical laboratories. Data was gathered from 778 institutions in Australia, Canada and the United States. The study showed that a ratio of accidental skin puncture events to all others types of accidents and events was 1.44. That is, for every 144 skin puncture events there are only 100 other non-puncture events. In particular, the number of incidents while performing phlebotomy was 24.5 percent of all incidents. A study of high-risk employees over a 12 month period showed that the median number of needlestick or sharp injuries was six. Such data indicates a critical need to have a device to help protect the phlebotomist from needlestick injuries.
A needlestick incident is possible when the needle of the syringe becomes exposed by the health care person when collecting a body fluid sample. A number of devices have been used to keep the needle of the syringe covered prior to and after collecting the sample. In U.S. Pat. No. 4,737,149 a needle cap is held by a resilient shield during collection and transfer of the sample. This shield is only for holding the cap for covering the syringe needle. In U.S. Pat. No. 4,917,672 a sleeve is provided for the end of the syringe needle to shield the needle and keep it from dulling. This sleeve does not facilitate the transfer of body fluids to other containers. The single syringe cap holding device of U.S. Pat. No. 4,981,476 holds one small diameter cap using a U-shaped strip of a resilient sheet to wedge the cap between two apertures in the strip. A planar front plate has an upstanding lip extending around its periphery to limit an errant needle from slipping off the plate. Only a single cap can be held in this device. This is also a recapping device.
In the normal process of collecting a body fluid from a patient and processing this fluid for further analysis, a portion of the body fluid is transferred from a syringe to at least one evacuated test tube. The use of a syringe is desirable in performing phlebotomy tasks as the blood extraction rate can be controlled such that the veins of the patient do not collapse. The syringe needle must then be aligned with the test tube and the rubber stopper in the top of the tube must be penetrated by the needle. A considerable amount of skill is required to safely perform this task, especially in a dark room with a patient which may be moving. Frequently, however, this transfer is the task being performed when the needlestick incident occurs. Devices to protect the hand of the health care person in the transfer of body fluid to a single test tube are disclosed in U.S. Pat. Nos. 4,840,618 and 5,314,413.
The device disclosed in U.S. Pat. No. 4,840,618 holds a single test container and has a shield portion on the upper end of a handle. A pair of cutouts in the handle allows the contents of the container to be observed and a test tube to be held in the handle by a hand of an operator when the syringe needle is being extracted from the test tube. The shield has a ridge on the peripheral edge of the shield should the needle attempt to slide off the edge. This single test tube device does not provide for multiple test tubes to be sequentially filled from one syringe of body fluid.
The need to have a device to hold different size test tubes is recognized in U.S. Pat. No. 5,314,413. A number of test tube or vial openings are rotatably disposed on a shield plate having a deflector ridge. A handle is provided to support the shield plate and a thumb and forefingers are used to support the vial when being filled and when pulling the needle from the vial. A pinching type grip is required to support the vial using this vial handler tool and only one vial can be filled before an interchange of vials in the tool.
With a single collection of a body fluid from the patient a number of test tubes can be partially filled. The purpose of multiple tubes is that there are certain tubes used only by the chemistry lab, other tubes are used by the hematology lab, additional tubes are used by the blood bank, and so on. The ordering physician usually requests a variety of tests that require the use of 3 to 4 different tubes at one time. These tubes vary in size from about 1.2 millimeter in diameter to about 1.6 millimeter in diameter depending on the type of test and the laboratory doing the test.
Devices that hold a number of test tubes are disclosed in U.S. Pat. Nos. 4,982,850 and 5,330,439. In U.S. Pat. No. 4,982,850 five vertical shafts for housing vials are illustrated. An oval base and a overlying horizontal shield having an outer edge help support the device on a table and protect the hand of the health-care professional. The user can press each vial against the back of a respective shaft through a frontal slot in each shaft to hold the vials steady while inserting and removing the syringe needle. It is necessary to have a vial in each shaft to prevent an errant needle from entering a shaft and penetrating the hand of the user. Only certain vials can be held at any one time by the thumb of the user when transporting the holder.
The device of U.S. Pat. No. 5,330,439 has a detachable safety overshield with a projecting peripheral rim to catch the depositing needle and keep it on the face of the overshield. A collection tube retainer having one or more tubes therein is held in the hand of the user. The tube retainer does not protect against tube breakage. The safety overshield is attachable to the top of the tube retainer and covers the stopper of the collection tubes to hold the tubes in place during insertion and removal of the syringe needle. Once again, there is only limited protection for the hand of the user if all holes in the overshield are not filled with collection tubes.
An unsatisfied need remains to have a hand held device that holds one or a number of test tubes and fully protects the hand of the health-care professional during the transfer of syringe collected body fluid to the test tubes. The device needs to be economical to purchase, easy to use and assists the user in its proper operation.
Accordingly, an object of the present invention is to provide the health-care professional with a hand held device to make safe the transfer of body fluids from a syringe to a plurality of test tubes. This device should be useful in a laboratory as well as during direct care of the patient in the patient's room.
Another object of the present invention is to reduce the risk to exposure to injury and illness from direct contact with blood and other body fluids from a patient under the care of a care provider. Direct exposure from a needlestick injury is of a specific concern with the direct object of reducing the large percentage of such incidents.
Yet another object of the present invention is to provide a light weight hand held device which is easy to use to reduce the number of needlestick injuries to the high risk phlebotomist collecting many blood samples each work day. The device is to be designed to protected the hand of the user when a syringe needle is misaligned or misguided.
In still another object the hand held device is made to be used when filling a number of test tubes at one time from a single syringe. The device used in the process of collecting samples from a patient is to accommodate the physician ordering a variety of tests that require a variety of test tube sizes.